1. The Field of the Invention
The present invention is related to a blood seal having a spring-biased septum for use in connection with various medical devices. More specifically, the present invention relates to a blood seal having a spring-biased septum which is particularly adaptable for use in sealing a vascular access device immediately following placement of a catheter into a blood vessel of a patient.
2. Technical Background
During medical treatment, patients often require medication, blood, or fluids. The most efficient way of administering these substances is by depositing them directly into a patient's blood stream where the circulatory system quickly directs the substance to the target tissue or organ. Thus, vascular catheters for infusion of fluids, blood, and medications into patients are among the most commonly used medical devices. The insertion of a vascular catheter allows repeated or continuous access to the circulatory system of a patient. Vascular catheters are generally inserted into the extremities of a patient and fluids, blood, and medications are introduced to the patient through such catheters.
Catheters of this type are generally inserted into a vein or artery by means of an introducer needle. In one common configuration, the catheter is initially placed over the needle. The needle, with the catheter located over the needle, is inserted into the patient until the desired vein or artery is located. Once the needle and catheter are properly located in the vein or artery, the needle is withdrawn from the catheter and discarded. The catheter remains in the vein or artery to provide access to the circulatory system of the patient without repeated needle punctures.
When the catheter insertion and placement steps have been concluded, one end of a tube (or "tubing set") is generally attached to the proximal end of the catheter. The opposite end of the tube is attached to a source of fluid and medication. The source of fluid is typically a bottle or bag containing the fluid required for treatment of the patient. Once attachment of the catheter to the fluid source is completed, fluids are allowed to flow through the tubing, into the catheter, and ultimately into the patient. In most situations, fluids flow through the tubing set and into the patient by means of gravity feed or using a standard infusion pump.
It will be appreciated that it is important to minimize the leakage of blood to the outside environment during each of the steps described above. Blood leakage can expose medical personnel and others to blood-borne diseases such as AIDS and hepatitis. Blood leakage can contaminate equipment and supplies in the treatment area. Blood leakage may also cause unnecessary alarm on the part of the patient and other observers. Thus, it is important to prevent or minimize blood leakage in order to maintain safety, aesthetics, and to retain equipment and supplies in good working order.
The placement and use of catheters of the type described above involve the potential for blood leakage. For example, the removal of the introducer needle once the catheter is in place generally results in a short period of time during which blood may flow out of the catheter to the surrounding environment.
Attempts have been made to deal with the problem of blood leakage during the placement of catheters. Many of these solutions employ latex or polyisoprene barriers that restrict blood flow. Such a barrier is situated so that after venipuncture and introduction of the catheter into the blood vessel of a patient, the introducer needle is withdrawn through the barrier or plug. Unfortunately, most polymers, including those used in blood barriers, tend to take a set over time, especially if an object such as a needle, wire, or cannula remains in the plug for a prolonged period before use. As a result, when the needle is withdrawn through the barrier, the hole left by the needle may fail to reseal, allowing blood to leak from the device.
Other attempts to deal with the problem of blood leakage typically involve devices that are expensive and complex to operate. For example, one such device employs a relatively complex valve mechanism connected to the proximal end of the catheter which opens when a needle is inserted and then closes when the needle is removed. The valve then opens again when the tubing set is attached to the catheter. This device requires a mechanism for repeated opening and closing of the valve, as well as other collateral structures which facilitate operation of the device. These relatively complex structures complicate the device and add to its cost. In addition, the valve device is designed to remain in place after the tubing set is attached. This increases the potential for irritation and discomfort to the patient. Such devices are also too expensive for wide use in developing countries, where the problem of HIV infection is growing and the need for cost-effective solutions is great.
Accordingly, it would be an advancement in the art to provide a device which would control the flow of blood during the steps surrounding placement and use of a catheter. It would also be an advancement in the art to provide such a device which is inexpensive and simple to operate. It would also be an advancement in the art to provide such a device which could be used without requiring significant modification of conventional catheters, needles, tubing sets and the like. Finally, it would be a significant advancement in the art to provide such a device which provided the medical professional with more control in performing the tasks surrounding placement and use of a catheter.
Such apparatus are disclosed and claimed herein.